UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033443 |
|---|---|
| Receipt number | R000038136 |
| Scientific Title | Employment status of cervical cancer patient |
| Date of disclosure of the study information | 2018/07/19 |
| Last modified on | 2021/02/01 10:58:32 |
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Basic information
Public title
Employment status of cervical cancer patient
Acronym
Employment status of cervical cancer patient
Scientific Title
Employment status of cervical cancer patient
Scientific Title:Acronym
Employment status of cervical cancer patient
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Survey on the actual condition of employment status of cervical cancer patients
Basic objectives2
Others
Basic objectives -Others
The relationship between employment status of cervical cancer and self-efficacy, self-esteem, dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Employment status of cervical cancer patient
Key secondary outcomes
1)The relationship between employment status of cervical cancer patient and self-efficacy
2) The relationship between employment status of cervical cancer patient and self-esteem
3) The relationship between employment status of cervical cancer patient and dysfunction
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1)Patient aged from 20 to 64
2)Patient who have undergone any of the following treatments for cervical cancer and have been 6 months to 5 years after the start of treatment
(1) Cervical malignant tumor surgery and Lymph node dissection (including enforcement of adjuvant therapy)
(2) Concurrent Chemoradiation Therapy(including enforcement of adjuvant therapy)
3) Patient who is judged by primary doctor
4) Patient who gained consent to participate in research
Key exclusion criteria
1) Patient who had a diagnosis of other cancers within 5 years
2) Patient with cognitive impairment or mental disorders
3) Patient with distant metastasis or recurrence
4) Patient who are undergoing treatment for cervical cancer
5) Those who cannot understand Japanese to complete the questionnaire
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Komatsu Hiroko |
Organization
Keio University Graduate School of Health Management
Division name
Nursing
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL
03-5363-3733
komah@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iijima Miho |
Organization
Keio University Graduate School of Health Management
Division name
Nursing
Zip code
Address
4411 Endo, Fujisawa-shi, Kanagawa 252-0883 Japan
TEL
0466-49-6200
Homepage URL
h17701mg@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University Graduate School of Health Management
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学病院（東京都）
Keio University hospital（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Observational cross-sectional study
Measures
1)Self-efficacy
2)Self-esteem
3)Dysfunction
Management information
Registered date
| 2018 | Year | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038136
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
